Medication updates

Important information about your repeat carbimazole prescription

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the

Department of Health and Social Care in the United Kingdom, which is responsible for ensuring that

medicines and medical devices work and are acceptably safe.

The MHRA have recently issued an alert to advise doctors on the risks of patients being on

Carbimazole while pregnant. There is evidence that shows carbimazole usage at high doses

particularly in the first trimester can increase the risk of birth defects.

Carbimazole is used to treat high thyroid levels as well as being used in preparation for a

thyroidectomy (removal of the thyroid gland) and after radioactive iodine treatment in patients with

thyroid cancer.

In light of the recent alert, we are contacting patients who according to our records may be of

childbearing age to ensure that they are aware of the risks stated above. All patients are required to

see their specialist to determine if their carbimazole is appropriate to be continued in the event n

individual becomes pregnant.

If you think you may be pregnant or considering having a baby, we request that you contact the

practice as soon as possible so that your GP can refer you to see a specialist and have your

medication reviewed.

This information is relevant to patients taking pregabalin who are able to become pregnant. Pregabalin may also be called by its brand names Lyrica, Alzain, Axalid or Lecaent.

This safety leaflet is to help you understand the latest information about the effects of pregabalin

during pregnancy. Please keep this leaflet in a safe place as you may need to read it again.

• Pregabalin is a medicine used to treat nerve pain, anxiety, and some forms of epilepsy

• Taking pregabalin during pregnancy may slightly increase the chance of physical birth

abnormalities in the baby; the overall risk is low

• Do not stop taking pregabalin without discussing it with your prescriber; they are the best

person to talk to you about your individual situation

• If you are taking pregabalin, you should continue to use effective contraception during

treatment

• If you are currently planning to have a baby, it is important to discuss your treatment

options with your healthcare professional before you stop using contraception

• If you think you may be pregnant or need advice while taking pregabalin, talk to the

healthcare professional who prescribes pregabalin for you

What are the risks to unborn babies who are exposed to pregabalin?

Physical birth abnormalities can be caused by many different things. In the UK it is estimated that 2

or 3 babies in every 100 births are born with physical abnormalities. The risk (or chance) of

physical birth abnormalities is raised by certain medical conditions and in some cases the risk can

be increased by certain medicines taken during pregnancy. Some physical birth abnormalities may

need medical treatment.

We have carefully reviewed the results of a new study from 4 European countries. The study

showed that taking pregabalin during early pregnancy was associated with a slightly increased

chance of having a baby who is born with a physical birth abnormality. It is important to note that

this study could not show that pregabalin was the cause of the physical birth abnormalities.

The study focused on women who took pregabalin during pregnancy. In this study, 6 babies in 100

born to women who took pregabalin in the first 3 months of pregnancy had physical birth

abnormalities, compared to 4 babies in every 100 born to women who were not treated with

pregabalin or other epilepsy medicines in early pregnancy.

The study also showed a higher risk of physical birth abnormalities in unborn babies exposed to

pregabalin compared to another medicine for epilepsy (called lamotrigine) and another medicine

for anxiety and some forms of pain (called duloxetine).

This leaflet has been produced by the Medicine and Healthcare products Regulatory Agency (MHRA), an executive

agency of the Department of Health and Social Care. This information should be used as part of a discussion with a

doctor, nurse, or specialist. Keep it safe in case you need it again.

If you are planning a pregnancy, or think you may be pregnant

It is vitally important that you talk to a healthcare professional about treatments for your health

conditions during pregnancy. If you have a condition that requires long-term treatment, it is

especially important to ask your doctor whether any changes are needed to your medicines.

Untreated epilepsy, pain, or anxiety could be harmful to you and your unborn baby. It is important

that you talk to your healthcare professional before stopping pregabalin or making any changes to

your usual medicines.

If you’re planning a pregnancy, before you stop using contraception you should see your GP,

specialist, or nurse to jointly decide the best course of action in your individual situation.

They will discuss with you the options and the potential risks, including the risks of different

treatments and the risk of your medical condition not being treated. You and your healthcare

professional may agree that pregabalin is the safest option for you during pregnancy.

If you think you may be pregnant and are currently taking pregabalin, you should set up an

appointment with your GP, specialist or nurse at your earliest opportunity, to discuss any concerns

you may have. However, do continue to take pregabalin as prescribed until you can speak to them.

When planning a pregnancy, taking folic acid is generally recommended before you become

pregnant and in early pregnancy to support your baby’s development. Talk to your healthcare

professional who can recommend the right dose of folic acid for you.

Always read the Patient Information Leaflet that accompanies your medicine. If you have any

questions or concerns about pregabalin, talk to your healthcare professional.

If you are taking pregabalin for epilepsy

If you have epilepsy, never stop taking medicines such as pregabalin without medical advice.

Suddenly stopping epilepsy medicine may cause your seizures to start again, or happen more

often and last longer than before.

Different epilepsy medicines are associated with different risks in pregnancy. Information on this to

help patients and their families is in our Guidance on Epilepsy Medicines and Pregnancy

https://www.gov.uk/government/publications/epilepsy-medicines-and-pregnancy.

Further sources of information

Further advice can be obtained from your doctor, nurse, specialist or pharmacist. Information and

support is available from charities such as:

• Pain UK: www.painuk.org/members/charities

• Anxiety UK: www.anxietyuk.org.uk

• Epilepsy Action: www.epilepsy.org.uk

• Epilepsy Society: www.epilepsysociety.org.uk

Please report any suspected side effects associated with medicines taken during pregnancy or

breastfeeding, including any suspected effects on the baby or child. Medicine side effects should

be reported directly to the MHRA on the Yellow Card website, or via the free apps (‘Yellow Card

Scheme’ in the Google Play Store or ‘Yellow Card – MHRA’ in the Apple App Store), or by phoning

the free phoneline (0800 731 6789).

Last revised in April 2022 This advice will be reviewed in October 2022. This leaflet is available online at

www.gov.uk/guidance/pregabalin-and-risks-in-pregnancy. If you have any feedback regarding this leaflet, please email

info@mhra.gov.uk

Advice to provide to patients about Topiramate

• do not stop taking topiramate without first discussing it with your

doctor

• topiramate can harm the way an unborn baby grows and develops

during pregnancy – see advice on epilepsy medicines and pregnancy

• a new study has also linked topiramate to an increased risk of autism

spectrum disorders and intellectual disabilities (effects on learning and

development) in children exposed to it during pregnancy

• if you are taking topiramate for epilepsy and are planning a

pregnancy, urgently talk to your doctor for a specialist review – there

are other epilepsy medicines that are not associated with an

increased risk of birth defects in pregnancy

• if you are taking topiramate for migraine and planning a pregnancy,

talk to your prescriber about alternative treatments that can be used in

pregnancy as soon as possible

• anyone who is able to get pregnant should have a pregnancy test

before they start topiramate treatment and use effective contraception

while taking topiramate

• topiramate can reduce the effectiveness of hormonal contraception in

preventing unplanned pregnancy – talk to a healthcare professional

about the best contraception for you while you are taking topiramate

Dear patient

We are writing to you because we think you are taking a medicine called

valproate. Valproate can also be called other names, so see the list

below:

• Valproate

• Sodium valproate

• Semisodium valproate

• Valproic acid

• Epilim Chrono®

• Epilim Chronosphere®

• Episenta®

• Epival®

• Belvo®

• Convulex®

• Depakote®

• Dyzantil®

• Convulex®

• Orlept®

• Syonell®

You must have a review of your treatment every year.

Do not stop taking your valproate unless you have spoken to your

doctor or nurse. If you stop taking it, your condition might get

worse.

Important information you should know:

If you take valproate when you are pregnant, it can harm your baby in two ways:

• Birth defects when the baby is born.

• Problems with development and learning, including being late in learning to

walk and talk, lower intelligence than other children of the same age, and

memory problems as the child grows up.It is important that you do not get pregnant while you are taking valproate.

If you are between 12 and 55 years old, you must use contraception. You

must use it even if you are not having sex unless your doctor agrees you

do not need to.

What you should do:

If you have not had a review of your treatment in the past year

• Keep taking your valproate.

• Keep using contraception.

• Make an appointment with your doctor or nurse specialist as soon as

possible.

• Tell them you need to speak to them about whether valproate is still the best

medicine for you.

If you are pregnant, or think you might be:

• Keep taking your valproate until you talk to your doctor. If you stop taking it,

your condition might get worse. This might harm your baby.

• Make an appointment with your doctor as soon as possible.

• Tell them you are pregnant and taking valproate.

If you want to try for a baby:

• Keep taking your valproate until you talk to your doctor.

• Keep using contraception.

• Make an appointment with your doctor as soon as possible.

• Tell them you need to speak to them about valproate and pregnancy.

If you are not using contraception that has been specially recommended for you because you are taking valproate (ideally a coil or an implant):

• Keep taking your valproate.

• Keep using contraception.

• Make an appointment with your doctor or sexual health clinic as soon as

possible.

• Tell them you need to speak to them about pregnancy prevention and

valproate.

We are writing to every woman and girl aged 12 and over who takes valproate.

If you cannot possibly become pregnant because you are too young, too

old or some other reason, we are sorry if this letter has upset you.

If you have any questions about this letter, please visit

this webpage: https://www.england.nhs.uk/patient-

safety/sodium-valproate/

Yours Sincerely

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued safety alerts associated with the use of SGLT2 inhibitors (dapagliflozin, empagliflozin, canagliflozin or ertugliflozin):

Fournier’s gangrene

• Fournier’s gangrene is a rapidly progressing, tissue-destroying infection on the genitals and

nearby which is rare but potentially life-threatening.

• It commonly occurs in older men, but it can also occur in women and children.

• Seek urgent medical attention if you experience severe pain, tenderness, redness/blackening of

the skin, or swelling in the genital or perineal area, accompanied by fever or feeling unwell.

• If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor immediately and seek medical

advice.

• Link for more information: Fournier’s Gangrene: Causes, Symptoms, Diagnosis & Treatment

(clevelandclinic.org)

Diabetic Ketoacidosis (DKA) > applicable if you have a diagnosis of diabetes.

• DKA is a complication of diabetes that results from increased levels of a chemical called ketones

in the blood.

• Seek urgent medical attention if you experience excessive thirst, frequent urination, fatigue, and

/or vomiting.

• Risk factors for DKA include a low beta cell function reserve, conditions leading to restricted

food intake or severe dehydration, sudden reduction in insulin, increased insulin requirements

due to acute illness, recent surgery or alcohol abuse.

• Discontinue treatment with the SGLT2 inhibitor immediately if DKA is suspected.

• Link for more information: Diabetic ketoacidosis – NHS (www.nhs.uk)

Increased risk of lower-limb amputation > applicable if you have a diagnosis of diabetes and

are taking canagliflozin only.

• Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type

2 diabetes.

• Seek medical attention if you experience foot complications such as infection, skin ulcers,

osteomyelitis, gangrene, local swelling or pain, reddening of the skin or discharge.

• Risk factors include poor control of diabetes and problems with the heart and blood vessels.

• Maintain adequate hydration and ensure you have a foot check in primary care at diagnosis and

at least once a year thereafter, or sooner if any foot problems arise. This will be included in your

annual diabetes review with one of our nurses.

If you have any queries or would like more information, please get in touch and make an appointment with one of our GPs or Clinical Pharmacists.